Design verification can be a difficult stage for medical device companies to carry out effectively. This is especially true when quality engineers limit their testing activities to only take place during the research and development (R&D) process. In this episode, Mike Drues of Vascular Sciences joins me to discuss the nuances of design verification, as it relates to quality and design controls. Some of the highlights of the show include: ● The difference between design verification and design v...
Nov 07, 2019•41 min•Ep 119•Transcript available on Metacast Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the new European Medical Device Regulation (EU MDR) continue to create angst and uncertainty. In this episode, Andrew Wu and I discuss the ramifications of these changes. Andrew is a software consultant with Rook Quality Systems and software as a medical device (SaMD) expert. Some of the highlights of the show include: ● Most noticeable change is a broader definition of what qualifies as a medical devic...
Nov 07, 2019•37 min•Ep 118•Transcript available on Metacast FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devices and combination devices eligible through the Breakthrough Devices Program (BDP). Requirements for eligible devices include those that significantly improve the safety of currently available treatments or diagnostics for underlying diseases or conditions associated with less serious morbidities and mortalities. Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to discuss how...
Nov 07, 2019•34 min•Ep 122•Transcript available on Metacast Did you know that the Apple Watch was recently granted de novo classification requests by the FDA? Pretty exciting news for the medical device industry, which is experiencing a crossover of traditionally consumer goods and technology. For example, health insurance providers and wellness programs are starting to adopt such wellness products. So, expect more technologies to enter the medical device realm in the near future. In this episode, Mike Drues and I discuss this trend and related programs....
Nov 07, 2019•34 min•Ep 85•Transcript available on Metacast It’s time to recap what happened in the medical device industry this year and start to think about what’s expected to happen in 2019. Some of the highlights of the show include: ● 2018 Prediction #1: It’s going to be harder for medical devices to get to market and stay in the market in EU. Still confusing; clarity to come in 2019? ● 2018 Prediction #2: Mad dash to update ISO 13485 certification before deadline. Resources were constrained, some came late to the party, progress was made. ● 2018 Pr...
Nov 07, 2019•16 min•Ep 87•Transcript available on Metacast Have you heard the news? FDA caused quite a stir when it recently announced transformative changes that will modernize its 510(k) program to improve the safety and effectiveness of medical devices. But as we all know, the more things change, the more they stay the same. If you dive deep into FDA’s statement, you’ll realize that there’s probably not a lot that’s different. In this episode, Mike Drues, of Vascular Sciences, and I offer an initial reaction to these changes. Some of the highlights o...
Nov 07, 2019•32 min•Ep 86•Transcript available on Metacast What are Voluntary Consensus Standards? Why should you care about them? What role do they play in your regulatory submission process? In this episode, Mike Drues of Vascular Sciences and I discuss the importance of such standards that affect medical device professionals. Some of the highlights of the show include: ● Guidance and regulation are voluntary. You can comply or not. If something doesn’t make sense, justify why and describe what you plan to do instead. ● FDA’s guidance document provide...
Nov 07, 2019•30 min•Ep 88•Transcript available on Metacast What does true quality mean? How does it relate to compliance? Today’s guest on The Global Medical Device Podcast is George Zack of Two Harbors Consulting. George shares his thoughts on these two tough questions and describes his involvement with the FDA’s Case for Quality Program and CMMI Institute’s Medical Device Discovery Appraisal Program (MDDAP). Some of the highlights of the show include: ● MDIC oversees programs developed to assess organizations’ beyond compliance of regulations to produ...
Nov 07, 2019•38 min•Ep 89•Transcript available on Metacast It doesn’t matter how long a company has been in business. Startups to established companies need to remain focused on the value proposition of its device product development efforts. Today’s guest is Scott Phillips, CEO of StarFish Medical. He offers advice on how to approach value proposition depending on the stage of your business. Some of the highlights of the show include: ● What does your company value? Point priorities in the right direction. ● Founders start a company because they want t...
Nov 07, 2019•33 min•Ep 92•Transcript available on Metacast Do you know the difference between quality management system (QMS) and quality systems management (QSM)? Today’s guest is Larry Mager of Mgmt-Ctrl. He describes the difference between QMS and QSM, as well as offers tips on concepts that make medical device businesses more efficient and effective to benefit patients. Some of the highlights of the show include: ● Challenges with management control include the different definitions of quality management. Most organizations define it too narrowly an...
Nov 07, 2019•32 min•Ep 90•Transcript available on Metacast Regulatory compliance is critically important. However, some think product liability is just as important, if not more. Today’s guest is Mike Drues of Vascular Sciences and we discuss how companies shouldn’t fear the FDA and its regulations. Instead, they should have a healthy respect for the FDA. Who should they fear? Product liability attorneys because they can cause much more damage to a company than the FDA. Some of the highlights of the show include: ● You may not be limited to what the FDA...
Nov 07, 2019•37 min•Ep 91•Transcript available on Metacast Human factors and risk create a lot of confusion in the medical device industry. What do you need to do from a design control perspective? Today’s guest is Mary Beth Privitera, principal - human factors at HS Design and AAMI Human Engineering Committee co-chair. She describes the similarities and differences between human factors vs. design validation. Some of the highlights of the show include: ● What constitutes human factors validation? It involves an international standard and FDA guidance o...
Nov 07, 2019•34 min•Ep 93•Transcript available on Metacast Does your medical device company prefer to outsource the responsibility of its quality management system (QMS) to a third-party supplier? Companies need to understand the ramifications of not owning, managing, and maintaining its QMS. Today’s guest is Mike Drues of Vascular Sciences. In this episode, Jon Speer and Mike discuss reasons why contract manufacturers should or should not own your company’s QMS. Some of the highlights of the show include: ● There’s an alarming and risky interest for co...
Nov 07, 2019•24 min•Ep 94•Transcript available on Metacast FDA has been busy working on guidance documents, including Nonbinding Feedback After Certain FDA Inspections of Device Establishments. Mike Drues of Vascular Sciences joins Jon Speer on the Global Medical Device Podcast this week to discuss the importance of this document and how it relates to 483 observances and warning letters for medical devices. Some of the highlights of the show include: - What prompted nonbinding feedback guidance, and is it necessary? CDRH’s increased number of site inspe...
Nov 07, 2019•38 min•Ep 96•Transcript available on Metacast When should you begin to consider human factors with your medical device design and development efforts? There are some simple and straightforward actions to assess human factors needs sooner than later. Today’s guest is Mary Beth Privitera, principal - human factors at HS Design. She explains how it is a bit of a conundrum to know how and when to implement human factors because of standards and guidelines that create confusion. But don’t be afraid! Continue to develop products that improve peop...
Nov 07, 2019•34 min•Ep 95•Transcript available on Metacast FDA recently released a new guidance document titled, Safety and Performance Based Pathway, which pertains to its Premarket Notification 510(k) process. Today’s guest is Mike Drues of Vascular Sciences and in this episode, Jon Speer and Mike discuss the meaning and purpose behind this new guidance. The draft version of the guidance was Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria. Some of the highlights of the show include: ● The...
Nov 07, 2019•39 min•Ep 97•Transcript available on Metacast It seems like every time you turn on the TV, there’s commercials, movies, and shows that highlight the use of artificial intelligence (AI) and/or machine learning (ML). The current trend of using AI and ML is even finding its way into medical devices. Recently, the FDA issued a press release about the potential of AI and ML to fundamentally transform the delivery of health care. This episode’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to discuss nuances, regulations, and impl...
Nov 07, 2019•38 min•Ep 98•Transcript available on Metacast Drumroll, please. It’s time to celebrate the 100th episode of the Global Medical Device Podcast! Jon Speer, 2-series podcast host, VP of QA/RA and founder of Greenlight Guru, reflects on some of his favorite moments and highlights through the years. “I’m a product development nerd. I’m a design control nerd. I geek out when I get to talk to some folks.” Some of the highlights of the show include: ● Human Factors: Mary Beth Privitera and Bryant Foster ● Design Controls and Product Development: Da...
Nov 07, 2019•12 min•Ep 100•Transcript available on Metacast Do you love quality and regulatory and keeping up with all things related to the medical device industry? There’s never a shortage of changes to learn about. Greenlight Guru is traveling around the country to bring medical device professionals together and provide up-to-date insights on the latest quality and regulatory trends. This special episode features a recording of the industry panel from the Greenlight Guru True Quality Roadshow in Atlanta, presented by the Global Center for Medical Devi...
Nov 07, 2019•37 min•Ep 99•Transcript available on Metacast Biocompatibility can be challenging and frustrating when developing a medical device. Why do you have to spend time and money to do the same testing, if the materials used in your device have already been tested, approved, and put in medical devices on the market? Biocompatibility impacts the majority of medical devices. Today’s guest is Josh Crist, a biocompatibility expert who used to work for the FDA and is now with Biologics Consulting and he and Jon discuss the nuances of biocompatibility. ...
Nov 07, 2019•38 min•Ep 102•Transcript available on Metacast Is de novo a realistic regulatory pathway? Or, the “kiss of death” for your product? No, to de novo? Think again. Who cares about de novo? We do! Today’s guest is “Dr. De Novo “(a.k.a. Mike Drues of Vascular Sciences), who describes how to make de novo a viable option for your medical device. Some of the highlights of the show include: ● For years, use of de novo was rare; fewer than five devices were brought to market. MDUFA stats state FDA received 56 de novos in 2018; 18 in 2019. ● Congress d...
Nov 07, 2019•38 min•Ep 101•Transcript available on Metacast Greenlight Guru continues to bridge the gap in biomedical engineering education by helping students learn and understand the importance of quality systems, design controls, and risk management. By collaborating with the Joint Department of Biomedical Engineering (BME) at the University of North Carolina and North Carolina State, Greenlight Guru’s efforts benefit both students and staff. Today’s guest is Devin Hubbard, UNC/NCSU teaching assistant professor, who describes how Greenlight Guru has m...
Nov 07, 2019•36 min•Ep 104•Transcript available on Metacast Feeling gloom, doom, concern, and fear about the new European Union Medical Device Regulation (EU MDR)? In this episode, Rebecca Sheridan shares some positive insights and updates regarding EU MDR and its In Vitro Diagnostic Regulation (IVDR). Rebecca is a former regulator herself, and now serves as Senior Director for Quality Assurance, Regulatory Affairs, and Clinical Affairs for the Advanced Wound Franchise of ConvaTec Limited. Some of the highlights of the show include: ● EU MDR transition t...
Nov 07, 2019•32 min•Ep 103•Transcript available on Metacast The relationship between human factors and design controls often creates confusion in the medical device industry. Today’s guests are Russ Branaghan and Bryant Foster from Research Collective, a human factors and user experience consultancy. In this episode we discuss how to integrate human factors into design controls to reduce risk and improve patient outcomes. Some of the highlights of the show include: ● Research Collective helps design medical devices that are easy to learn and efficient to...
Nov 07, 2019•42 min•Ep 105•Transcript available on Metacast The medical device industry could be more proactive than reactive when managing systemic issues. We’re talking about the Corrective and Preventive Action (CAPA) process. In this episode, Jon Speer invites Mike Drues of Vascular Sciences to be his guest as they discuss the importance of the Corrective and Preventive Action (CAPA) process. Is your company CAPA happy? Some of the highlights of the show include: ● CAPA is a means to formally investigate a systemic issue and properly take actions to ...
Nov 07, 2019•35 min•Ep 106•Transcript available on Metacast The FDA recently decided to discontinue its alternative summary reporting program due to the allegation that millions of medical device reports (MDRs) that included product-related malfunctions were “hidden” and not disclosed to the public. In this episode, Mike Drues of Vascular Sciences joins the show to discuss the pros and cons of the program and what’s expected to happen because of its discontinuation. Some of the highlights of the show include: ● Depending on severity of malfunction, the p...
Nov 07, 2019•39 min•Ep 108•Transcript available on Metacast The medical device industry strives to develop high quality and innovative products that will contribute to the improvement of patients’ lives Today’s guest is Bruce Gingles, one of my first bosses and mentors as a medical device professional. He taught me about medical device product development and patients. Currently, Bruce is vice president of Global Technology Assessment and Healthcare Policy at Cook Medical. He’s also the co-author of Medical Innovation: Concept to Commercialization. Some ...
Nov 07, 2019•34 min•Ep 107•Transcript available on Metacast Software and other requirements are critically important to medical device product development. In this episode, Chris DuPont, co-founder and CEO of Galen Data, provides his best practices for listeners to consider with their medical device product development efforts. Some of the highlights of the show include: - The medical device industry is about 5-10 years behind the times with adopting state-of-the-art technology. - A successful medical device depends on accommodating requirements and stak...
Nov 07, 2019•32 min•Ep 111•Transcript available on Metacast As a medical device professional, do you know about Design History File Ready Ideation (DHFRI)? It’s an innovative and creative approach to product development. In this episode, Andrew DiMeo, Innovation and Design Coach at Trig, joins the show to discuss the reasons why he created DHFRI and its benefits. Some of the highlights of the show include: ● Andrew’s definition of DHFRI is holistic view of medical device development through collaboration across multiple functions. ● DHFRI uses four Canva...
Nov 07, 2019•37 min•Ep 109•Transcript available on Metacast From creating product codes to following regulations, do you ever wonder what goes on inside the U.S. Food and Drug Administration (FDA)? In this episode, Allison Komiyama of Acknowledge Regulatory Strategies is a former FDA reviewer and she shares with listeners some fun facts about the FDA and what we don’t see behind closed doors. Some of the highlights of the show include: ● Fun Fact #1: FDA employees are not all about rules and red tape. They’re passionate about public health and do things ...
Nov 07, 2019•30 min•Ep 110•Transcript available on Metacast 
